1. Field of the Invention
This invention relates to a combination container and air removal fixture for simplified filling of an implantable hydraulic device, such as, for example, an elastofluidic prosthetic sphincter, or the like with a continuous air-free supply of hydraulic fluid (e.g. such as radio-opaque fluid).
2. Prior Art
As will be recognized by those skilled in the art, hydraulic, implantable devices are commonly filled in the operating room at the time of implant using well-known bowls filled with hydraulic fluid and syringes to transfer the fluid from the bowls into the device. Entrapped air is removed from the device by repeatedly flicking the device while holding the syringe at a higher elevation then the device and drawing out a fluid-air mixture. However, this technique is awkward and sometimes not totally reliable for withdrawing all of the entrapped air from the device. As an improvement to the conventional filling technique, the implantable hydraulic device is first prefilled with an appropriate fluid and then immersed in the same fluid and sealed in a sterile package to ready the device for transfer from the package to a patient. This process is known as immersion packaging. However, immersion packaging has been known to result in certain problems and inconveniences. More particularly, because the device is prefilled, relatively deep penetration by sterilizing gases and/or radiation may not be possible, thereby reducing the overall efficiency of sterilizing procedures. In addition, a problem arises in the handling and disposing of the immersion fluid which surrounds the device. That is, after the device has been unpackaged, the physician must take the time to dispose of the excess fluid in which the device was immersed. This process if often inconvenient and results in the waste of hydraulic fluid. Moreover, care must be taken to avoid spillage, whereby to create an unsafe condition in the operating room. Consequently, the use of immersion packaging techniques has proved to be both relatively cumbersome and time consuming.
For an example of a patent relating to immersion packaging, reference may be made to U.S. Pat. No. 4,597,765 issued July 1, 1986 to William Klatt.